| Summary: | Laura N Gitlin1, Laraine Winter1, Marie P Dennis1, Walter W Hauck21Center for Applied Research on Aging and Health (CARAH), Thomas Jefferson University, Philadelphia, PA, USA; 2Formely Division of Biostatistics, Department of Pharmacology and Experimental Therapeutics, Thomas Jefferson University, Philadelphia, PA, USA. Currently Sycamore Consulting, LLC New Hope, PA, USA; 3Funded by the National Institute on Aging and the National Institute on Nursing Research (Grant # R01 AG22254). Clinical trial registration #NCT00259480.Abstract: Project ACT is a randomized controlled trial designed to test the effectiveness of a non-pharmacological home-based intervention to reduce behavioral and psychological symptoms of dementia (BPSD) and caregiver distress. The study targets 272 stressed racially diverse family caregivers providing in-home care to persons with moderate stage dementia with one or more behavioral disturbances. All participants are interviewed at baseline, 4-months (main trial endpoint), and 6-months (maintenance). The four-month intervention involves up to 13 visits from an occupational therapist who works with families to problem-solve potential triggers (communication style, environmental clutter) contributing to behaviors, and instruct in strategies to reduce caregiver stress and manage targeted behaviors. To rule out infection or other potential medical contributors to behaviors, a nurse obtains blood and urine samples from the dementia patient, and conducts a medication review. Participants in the no-treatment control group are offered the nurse arm and one in-home session following trial completion at 6-months. This paper describes the research methods, theoretical and clinical aspects of this multi-component, targeted psycho-social treatment approach, and the measures used to evaluate quality of life improvements for persons with dementia and their families.Keywords: family caregiving, environmental modification, home care, occupational therapy, psychosocial intervention
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